Effect of an Extract of Green Tea on Adults With Type 2 Diabetes
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Purpose
The objective of this study was to determine if taking an extract of green tea for three months could improve glucose control in adults with diabetes.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes |
Drug: Extract of Green and Black Tea |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | The Effect of an Extract of Green Tea on Glucose Control in Adults With Type 2 Diabetes |
- HbA1c
| Estimated Enrollment: | 48 |
| Study Start Date: | August 2005 |
| Estimated Study Completion Date: | June 2006 |
Background: Recent evidence suggests that tea from Camellia Senensis (e.g., green, oolong and black tea) may have a hypoglycemic effect.
Objective: We evaluated the ability of an extract of green and black tea to improve glucose control over a three month period using a double blinded randomized multiple dose (either placebo, 375mg or 750mg) study in adults in with Type 2 Diabetes.
Patients: The 49 subjects who completed this study were predominantly whites with an average age of 65, a median duration of Diabetes of 6 years, and 80% reported using hypoglycemic medication.
Measurements: HbA1c at three months was the primary endpoint. Results: After three months the mean changes in HbA1c were +0.4, +0.3 and +0.5, in the placebo, 375mg and 750mg arms, respectively. The changes were not significantly different between study arms.
Limitations: Evaluation of a particular extract that contained components of black teas as well as green tea. Power insufficient to detect changes in HbA1c < 0.5.
Conclusions: We did not find a hypoglycemic effect of extract of green tea in adults with Type 2 Diabetes, but cannot rule out the possibility that tea may have a small beneficial effect.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adults with Diabetes not taking insulin
Exclusion Criteria:
- pregnancy, warfarin therapy
Contacts and Locations| United States, New Hampshire | |
| Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756 | |
| Principal Investigator: | Todd A MacKenzie, PhD | Dartmouth-Hitchcock Medical Center |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00389350 History of Changes |
| Other Study ID Numbers: | Hitchcock Tea 1 |
| Study First Received: | October 16, 2006 |
| Last Updated: | October 17, 2006 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013